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21st Century Approaches to Risk Sciences

Long-Range Research Initiative- Global Research Strategy21st Century Approaches to Risk Sciences

The Long-Range Research Initiative (LRI) of the American Chemistry Council (ACC) promotes innovations in chemical safety assessment. It invests in science essential for understanding the impact of chemicals on human health and the environment.

LRI’s mission is to foster a sustainable and healthy future through support of high quality science that targets the science-policy interface and advances the science used in decision-making.

21st Century Approaches to Risk Sciences

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Long-Range Research InitiativeGlobal Research Strategy21st Century Approaches to Risk Sciences

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LRI Global Research Strategy - Priority Areas21st Century Approaches to Risk SciencesEmerging Technologies – Assessing innovative tools, approaches,and data for robust, timely, and resource-effective evaluations ofchemicals as well as new technologies, such as nanotechnology.Exposure Science – Improving the tools to quantify everydayand incidental exposures to chemicals and to guide intelligenttesting and risk assessment.Translation Relevant to Health and Environment –Developing approaches and tools to improve understandingof links between exposures to chemicals and their potentialeffects on human health and the environment.

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Executive SummaryThe innovative research program of the International Councilof Chemical Associations’ Long-Range Research Initiative(ICCA-LRI) is designed to improve the quality of chemical safetyassessments. This global program and its research strategytarget the science-policy interface to modernize and improvechemical management. Although societal and political driversvary around the world, the three regional LRI programs in Europe,the United States, and Japan identify common scientific topicareas that industry regards as important to form the core ofthe global ICCA-LRI program and direct its research strategy.This LRI Global Research Strategy, 21st Century Approachesto Risk Sciences, comprises three priority areas: emerging 1technologies, exposure science, and translation relevant tohealth and environment. The research funding invested in thesethree areas is often leveraged through collaboration with publiclyfunded projects that can maximize project value up to fivetimes. Through a rigorous governance structure involving chiefexecutive officers (CEOs) and directors general from the threeLRI regions, strategic alignment, complementarity, efficient useof financial resources, and effective dissemination of researchresults are achieved. The ICCA-LRI is recognized as a brand thatdemonstrates industry engagement within Responsible Care®,provides early warning on emerging issues, achieves outreachto opinion leaders through its network, and supports capacitybuilding within industry to ensure knowledge-based decisionmaking by companies and by public policy makers.

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Introduction Background The importance of science to decision making about the safety The LRI programs at Cefic, ACC, and JCIA sponsor of chemicals is more evident today than ever before. Demands independent third-party research that enhances the credibility are increasingly heard for more data, better information, and of LRI-funded science. A unifying focus for these programs science that can drive decisions to improve the quality of is to improve the way we address the safety of our chemicals, public health and the environment. At its core, the business particularly with regard to everyday exposures of employees, of chemistry is all about science – science aimed toward consumers, and the general public to low levels of chemicals. innovations in products and services that can make people’s Through the perspectives and expert guidance provided lives better, healthier, and safer. Science is also an essential by scientists from industry, academia, and governmental part of the process needed to inform good decisions. agencies, LRI-supported research provides critical information to government and industry regarding risk assessment2 Since 1999, the ICCA-LRI has supported the science to decisions about the potential health and environmental impacts address these issues and the demands of decision makers and of chemicals. The LRI also extends the chemical industry’s the public to understand the impact of chemicals on human commitment to Responsible Care, strengthens the basis for health and the environment. The LRI is a global program harmonized regional and international chemical policies, implemented through three ICCA member organizations – the and supports establishment of reliable frameworks for safety European Chemical Industry Council (Cefic), the American evaluation and innovation. Chemistry Council (ACC), and the Japan Chemical Industry Association (JCIA). Through the ICCA, these regionally managed LRI research programs support complementary areas of scientific investigation.

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LRI MissionThe mission of the LRI is to identify and fill gaps in our understanding about the hazardsposed by chemicals and to improve the methods available for assessing the associated risks.Its innovative research programs are designed to improve the way we address the safetyof our chemicals, particularly everyday exposures of consumers to low levels ofchemicals and chemical mixtures. The LRI fosters a sustainable and healthy futurethrough its support of high-quality science that can informeffective decision making by industry,regulators, and society.

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Purpose of the Strategy Developing and implementing an effective LRI research This Strategy considers the LRI program as a whole, program requires guidance from a strategic plan as well as independent of which regional LRI program manages the effective processes designed to achieve coordination among research. Each regional LRI program is responsible for the three regional LRI programs. This LRI Global Research examining the relationship of its research program to the Strategy outlines the direction for the LRI research program in Strategy’s overall objectives and for ensuring alignment. three priority research areas: emerging technologies, exposure The ICCA-LRI Planning Group (PG), whose composition and science, and translation relevant to health and environment, responsibilities are described on page 15 of this document, based on a five-year timeframe. This document also describes works to ensure coordination among the LRI programs in the guidelines and processes used by the LRI to achieve its Europe, the United States, and Japan within an agreed-upon research objectives. set of principles and broad technical issues. The regional LRI4 programs share common objectives, but each program is targeted towards industry policy priorities within its region. The PG’s goals include sharing information and experiences and ensuring that the regional LRI programs are complementary and that no unnecessary duplication exists among the research projects in the three programs.

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LRI Goals and Principles Through its commitment to the LRI, the global chemical industry is recognized as an informed and knowledgeable partner in worldwide efforts to improve scientific understanding of the potential impacts of chemicals on human health and the environment. LRI Principles The goals of the LRI are: Chemical Industry Relevance. Research• Extend knowledge worldwide on the health, safety, and needs and priorities will be determined based environmental impacts of the chemical industry’s products on the relevance of the research to the chemical industry and the overall goal to fund research and processes. that increases scientific understanding about• Support informed decision making and risk management the potential health and environmental impacts 5 decisions by increasing scientific understanding of chemicals. through research. Scientific Excellence. Research will focus on• Develop new tools to assess chemicals, especially as scientific excellence by identifying and engaging new questions emerge about potential health and the best scientists and having as its primary environmental impacts. goal advancement of scientific understanding.• Coordinate research among ICCA member associations to Transparency and Action. The research achieve international scientific participation in the research process will be transparent, the results process and create synergy among the research projects. will be publicly available, and industry will• Improve public confidence in decisions based on a scientific act on the results in a timely fashion. understanding of risk. Fair and Unbiased Conduct. Review of To achieve significant scientific advances in its funded research proposed research will identify possible conflicts projects, the LRI developed principles to govern its conduct; of interest and the potential for bias in decision these principles are consistent with Responsible Care goals. making will be monitored continuously.

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LRI Program Drivers Implementation of Registration, Evaluation, Authorisation and A variety of current issues underscore the critical need by Restriction of Chemicals (REACH) in the EU … reform of the society and industry to advance the science of risk assessment Toxic Substances Control Act (TSCA) in the United States for chemicals and corroborate the value of the chemical … revision of the Chemical Substances Control Law (CSCL) industry’s investment in the LRI. They include: in Japan ... the industry’s obligations under the Strategic • Advancing Approaches for Risk Assessment and Approach to International Chemicals Management (SAICM ) … Risk Management. Improving risk assessment methods, de-selection pressures. Globally, these drivers have motivated including innovative approaches to improve understanding of the industry’s product stewards and those in governmental and human exposures and advance evaluation of aggregate and regulatory agencies to seek high-quality scientific information cumulative risks, will enable more accurate interpretations of about chemical risks to better inform these current issues. This information derived from both existing and new studies. Such information is crucial to risk assessment, risk management,6 improvements will also provide key information to industry and risk mitigation and, ultimately, is the basis for making and regulators about the most effective and efficient risk good decisions about chemical management strategies. assessment and management strategies. Similarly, the general public is demanding better information about the safe use of chemicals, an essential element for • Emerging Technologies for Toxicity Testing. New biological improving its confidence in our products. research tools, such as genomics, high-throughput assays, computational models, and bioinformatics to analyze extensive data sets, have the potential to revolutionize risk assessment. These tools also have an important role in the design of intelligent testing strategies, which are integrated knowledge- based approaches aimed toward reducing costs and animal use and accelerating risk assessment. A critical element for successful integration of the data from these tools into risk assessment practice will be developing approaches to effectively interpret the data and to identify actual human health risks.

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• Improving Exposure Science. Information about exposures • Public Demands That Industry “Know Its Products.” to chemicals is as important as hazard information to Through Responsible Care, the chemical industry is committed appropriately assess human health risks. This particularly to understanding the potential health and environmental applies to everyday exposures to chemicals. Meaningful risks associated with the production, use, and disposal of its exposure data are needed to understand the health implications products. Through its research support, the LRI is advancing of data from biomonitoring studies, the ecological impacts use of state-of-the-art methods and technologies in health of chemical exposures, and the effects of indoor air quality and environmental science to address these risk concerns so on human health. Innovative tools to characterize and predict that industry can meet its product stewardship commitments environmentally relevant exposures are essential to address all effectively and efficiently. of these issues. • Alternatives to Animal Testing. The LRI supports• Demands for Increased Knowledge about Health Risks development of testing and research methods that reduce 7 to Susceptible Populations. Children are a susceptible the unnecessary use of animals. This goal may be realized population because they have the potential for higher through (1) developing or improving animal tests so that they exposures compared to adults for some chemicals and provide high-quality data using fewer animals; (2) devising have increased biological sensitivity due to their developing new methods, such as those that utilize cell lines, including physiological systems (e.g., nervous system, reproductive human cell lines, that avoid the use of animals while providing system). Other populations at increased risk for health effects meaningful results; and (3) improving methods that use from chemicals include workers, the elderly, and those with genomic technologies and have the potential to reduce reliance compromised health status. Through the LRI, the chemical on animal testing over the long term. industry is innovating improved screening and testing methods as well as advancing exposure assessment approaches to better understand health risks for children and other susceptible populations.

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LRI Global Research Strategy 21st Century Approaches to Risk Sciences The LRI Global Research Strategy is designed to directly These priority areas, which by design are interrelated and address many of the complex challenges faced by the industry interdisciplinary, provide an overall structure for the global LRI as it advocates for sound chemicals management policies. program. However, the focus on different topics within these The current Strategy, 21st Century Approaches to Risk priority areas may vary from year to year and from region to Sciences, targets the science-policy interface to modernize region depending on budget and other drivers. On balance, the and improve chemical management. The Strategy incorporates regional diversity adds both depth and texture to the ICCA-LRI three priority areas: research program. The text that follows and the accompanying table provide an overview of the 2010 research topic areas. • Emerging Technologies – Assessing innovative tools, approaches, and data for robust evaluations of chemicals as In the area of emerging technologies, JCIA leads in the8 well as new technologies, such as nanotechnology. application of technologies to understand how chemicals act on biological systems; ACC’s focus is on developing new • Exposure Science – Improving the tools to quantify everyday bioinformatic tools to interpret the data and apply it to risk and incidental exposures to chemicals and to guide intelligent assessment; and Cefic leads in the development of predictive testing and risk assessment. models and decision frameworks as well as in acceptance • Translation Relevant to Health and Environment – of new product areas, such as nanotechnology, to guide Developing approaches and tools to improve understanding intelligent testing strategies. of links between exposures to chemicals and their effects on With regard to exposure science, ACC has a program to link human health and the environment. exposure to hazard assessment and improve chemical safety and risk assessments; JCIA’s research program has a focus on ecological impacts of chemical exposures and on exposure- dose relationships for risk assessment; and Cefic has a strong program in real-life exposures and modeling and developing assessment frameworks for exposures from multiple sources, including chemical mixtures.

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For translation relevant to health and environment, Cefichas a focus on children’s health, including relevance of clinicalindicators and improved assessment methods to reduceuncertainty, as well as on emerging issues, such as animalwelfare and endocrine disruptors; ACC’s research programaddresses methods and models for improving human healthrisk assessment; and JCIA’s research program addressessick building syndrome and immune responses as well asassessment and application of human health risk assessment. 9

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Translation for Decision MakingOutreach and communication, elements that are integral to ICCA-LRI workshops, another element of the translationthe ICCA-LRI program, are essential for translating research component, showcase the global impact of ICCA-LRIfindings into information that can be used for science-based supported science. Since 2005, these workshops havedecision making. All results from the scientific research addressed a range of key issues relevant to the chemicalsupported by the LRI are openly communicated to the public, industry, such as human biomonitoring, 21st century methodsthe scientific community, and government regulators through for risk assessment, and emerging issues in exposure science.a variety of media approaches, including peer-reviewed They provide important, dynamic forums that foster interactionspublications, workshops, conferences, and the Internet. among industry and academic researchers, governmentalHowever, these communication outlets are only one aspect of agencies, non-governmental organizations, and regulatoryLRI’s approach to deliver impact and demonstrate the overall decision makers regarding areas of mutual interest in chemicalvalue of the program. The goals for the translation component management. Discussions among the diverse participantof the LRI Global Research Strategy are to facilitate use of groups promote improvements in the scientific basis for 11scientific innovations as part of the decision making process pragmatic policy making and support consensus buildingregarding the safety of our products, extend LRI’s network of that can advance risk and safety assessments for chemicals.science advocates through public dialogue and workshops, The following illustration provides a chrononology and briefand communicate a vision for new policy approaches for summaries of previous ICCA-LRI workshops.chemical management.

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12 ICCA-LRI Workshops Public Health Applications of Workshop on Making Sense of Human Human Biomonitoring Human Biomonitoring Biomonitoring Data Provided a venue for discussions Examined biomonitoring from the Fostered consensus on about the strengths and weaknesses perspectives of product stewardship, priorities for future research in of biomonitoring for the purposes policy/advocacy, communication, and biomonitoring for ICCA-LRI and of public health tracking, existing scientific knowledge gaps. other research organizations. intervention, and protection.‘05 ‘06 ‘07 paRis, Minneapolis, ReseaRch tRiangle paRk, FRance Minnesota, Usa noRth caRolina, Usa

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Connecting Innovations in Biological, Exposure, 13 Twenty-First Century and Risk Sciences: Approaches to Toxicity Better Information for Integrating New Advances Testing, Biomonitoring, Better Decisions in Exposure Science and and Risk Assessment Stimulated discussions about Toxicity Testing: Next Steps Addressed advances in the new interpreting the data from new Focused on the application of technologies for toxicity testing technologies and advancing risk- integrated approaches in exposure and biomonitoring; considered based decision making; reviewed science and toxicology to the approaches for effective innovative tools to characterize design, evaluation, and health communication of the deluge of data exposure and their implications risk management of chemicals; from these new technologies; and for health risk assessment; considered what research is needed promoted exchange of views on how and addressed the key role of to improve communication among these technological advancements communication to effectively scientists, stakeholders, and decision can be used to improve the science explain the emerging research makers to develop better chemical of human health risk assessment. outcomes to diverse audiences. management policies and practices.‘08 ‘09 ‘10 aMsteRdaM, chaRleston, stResa, the netheRlands soUth caRolina, Usa italy

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LRI Global Management and Governance Global Management Under the ICCA umbrella, Cefic, ACC, and JCIA have forged a • Link these global activities to ICCA priorities: virtual management and coordination structure that facilitates • Establish rapport and dialogue with global agencies (e.g., implementation of the LRI program with common goals World Health Organization, Organisation for Economic and principles. At the same time, this structure recognizes Co-Operation and Development, and United Nations the diversity among the scientific communities, regulatory Environment Programme) to ensure the industry is structures, and societal issues of the three geographical effectively addressing global concerns. regions of Europe, the United States, and Japan. • Provide a framework for participation and contribution by This management structure was initially established in October other organizations, including governments, industries, and 2004 to ensure trans-regional coordination for critical science- non-governmental organizations.14 based issues that are best addressed through implementation LRI continues its focus on innovations to advance the science of long-range research programs. This LRI Global Research of chemical risk assessment. A primary aim is to provide a Strategy extends the concepts and principles previously scientific foundation for the chemical industry, as part of the described in the 2005 version of this document. Recognizing larger global society, to make responsible product stewardship the growing global complexity of the many issues the chemical and regulatory decisions concerning the production, marketing, industry faces, this updated Strategy extends coordination of and use of its products. Substantial progress towards this aim regional activities to: has been realized through the strong commitment of each • Plan LRI activities with a global view that supports of the ICCA regional programs to the greater LRI vision. The coordination among the research programs while retaining success of the LRI Global Research Strategy has been and independent management by each region. continues to be based upon implementation of processes that increase transparency and integration among the regional • Design and implement a global program that addresses programs and create a venue for a comprehensive “one those issues for which consensus and endorsement from the industry” approach. ICCA-LRI Steering Committee exist.

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GovernanceICCA-LRI is a framework for coordination and collaboration The SC keeps abreast of emerging scientific issues that couldamong the three regional LRI programs that are funded and affect the global chemical industry, while maintaining a focusgoverned by their respective boards at Cefic, ACC, and on science-based decision making. The SC informs the ICCAJCIA. The ICCA-LRI Steering Committee (SC) oversees board about relevant issues and provides the industry withimplementation of this global framework. Through a rigorous an opportunity to establish a leadership role and to respondgovernance structure of the SC involving CEOs and directors proactively. The SC includes two CEO-level representativesgeneral from the three LRI regions, strategic alignment, from each of the three regional associations. The SC chair isresearch programs that support complementary areas of selected from the membership and rotates between Cefic andscientific investigation, efficient use of financial resources, and ACC every two to three years.effective dissemination of research results are achieved. The SC is supported by an ICCA-LRI Planning Group (PG) that 15 includes senior managers from each of the three LRI regions and is responsible for program management, efficient delivery of content, and dissemination of research results. Typically, the Governance of the LRI secretariat of the SC and PG rotates with the chair of the SC, but this rotation depends on staff availability. The SC meets once ICCA-LRI Steering Committee a year to coincide with the fall ICCA board meeting. The PG Six executive contacts, two each from the meets more frequently to ensure appropriate coordination and Cefic, ACC, and JCIA, who oversee the communication among the LRI regional programs. LRI and report to the ICCA board. ICCA-LRI Planning Group Senior company and association managers from the Cefic, ACC, and JCIA regional LRI programs, who provide support to the Steering Committee and feedback to their associations.

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LRI - Science in Action LRI’s research and advocacy for science-based decision In summary, the LRI, its research, and its translation program making provide a strong linkage to key ICCA advocacy facilitate use of scientific innovations in ways that can priorities and position the chemical industry as a leader and advance chemical management, better inform decisions knowledge partner in the broader community of science about safe use of chemicals, and lead to improved public and policy experts. Since 2005, LRI has been a global confidence in our products. The LRI program for innovating leader in interpretation of biomonitoring data through chemical risk assessment positions the chemical industry research, consensus-building among different entities, and as a leader and knowledge partner in the broader community communication of the scientific results, as well as other of science and policy experts. It will further ensure value outreach activities to governmental and non-governmental and relevance to other global programs, such as the ICCA agencies. LRI is currently investing in innovations for toxicity initiatives for high production volume chemicals and global testing to advance methods that are faster, more cost-effective, product strategy, that demand state-of-the-art methods to16 and responsive to animal welfare issues. Its broader program understand and communicate environmental risk information. in exposure science is also improving our understanding of the Research in the priority areas described in this LRI Global exposures of different populations to multiple chemicals in the Research Strategy, 21st Century Approaches to Risk Sciences, environment. Through the LRI and its research program, the extends the chemical industry’s commitment to safe chemical industry contributes significantly to the science that chemical management, strengthens the basis for regional will shape the future of chemical management policies. and international policies for chemicals, and facilitates establishment of a responsible framework for innovations in scientific research.

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From Data to Decisions: Informing Regulatory PolicyLRI research addresses the gap between new technologies and the science to interpret andunderstand the emerging data. Key questions include what research is needed to bridge thisgap; how to harness the data to better inform decisions about public health; and how best tocommunicate research outcomes as they evolve. Research QUESTIONS InformedLRI Policy Public Health Data COMMUNICATIONResearch Makers Interpretation INFORMATION Decisions